PlainRecalls

The Harvard Drug Group

42 recalls on record · Latest: Jul 5, 2023

The Harvard Drug Group Recall Insight

The Harvard Drug Group appears on 42 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.050% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jul 5, 2023, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 42 entries, severity tagging shows 1 critical, 33 moderate, and 8 lower-severity recalls. Affected-unit counts are disclosed on 41 of 42 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 3 distinct product categories, with issuing agencies dominated by FDA Drug (28), FDA Food (14). The date window on this page runs from Oct 19, 2016 to Jul 5, 2023.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Drug Moderate Jul 5, 2023

Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15…

FDA Drug Low May 17, 2023

Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA,…

FDA Drug Moderate Mar 8, 2023

Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. O…

FDA Drug Moderate Mar 23, 2022

hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 …

FDA Drug Moderate Mar 16, 2022

PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries …

FDA Drug Moderate Dec 29, 2021

Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livo…

FDA Drug Moderate Sep 29, 2021

Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India;…

FDA Drug Moderate Sep 29, 2021

Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 23…

FDA Drug Moderate Jul 21, 2021

NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC…

FDA Drug Moderate Dec 9, 2020

Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distribute…

FDA Drug Moderate Jul 8, 2020

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toron…

FDA Drug Moderate Jun 10, 2020

Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06),…

FDA Drug Low May 20, 2020

Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P…

FDA Drug Low Mar 18, 2020

Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454…

FDA Drug Low Mar 18, 2020

Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454…

FDA Drug Low Mar 18, 2020

Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454…

FDA Drug Low Mar 18, 2020

Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 4547…

FDA Drug Low Feb 26, 2020

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals,…

FDA Drug Moderate Oct 25, 2017

Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Go…

FDA Food Moderate Sep 20, 2017

Major Ferrous Drops, 1 2/3 oz (50 mL)

FDA Food Moderate Sep 20, 2017

Major CertaVite Liquid, 8 oz. (236 mL)

FDA Food Moderate Sep 20, 2017

Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL)

FDA Food Moderate Sep 20, 2017

Major Poly-Vita Drops, 1 2/3 oz (50 mL)

FDA Food Moderate Sep 20, 2017

Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL

FDA Food Moderate Sep 20, 2017

Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL)

FDA Food Moderate Sep 20, 2017

Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL)

FDA Food Moderate Sep 20, 2017

Rugby Calcionate Syrup, One Pint (473 mL)

FDA Food Moderate Sep 20, 2017

Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL)

FDA Food Moderate Sep 20, 2017

Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL)

FDA Food Moderate Sep 20, 2017

Major D-Vita Drops, 1 2/3 oz (50 mL)

FDA Food Moderate Sep 20, 2017

Rugby Ferrous Sulfate Liquid One Pint, (473 mL)

FDA Food Moderate Sep 20, 2017

Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL

FDA Food Moderate Sep 20, 2017

Rugby Cerovite Liquid, 8 oz. 236ML

FDA Drug Moderate Aug 30, 2017

Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Ent…

FDA Drug Moderate Aug 30, 2017

Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N.…

FDA Drug Moderate Aug 30, 2017

Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laure…

FDA Drug Moderate Aug 30, 2017

Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel P…

FDA Drug Moderate Aug 30, 2017

Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N …

FDA Drug Low May 10, 2017

Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceutic…

FDA Drug Moderate May 10, 2017

Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, …

FDA Drug Moderate May 10, 2017

Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, …

FDA Drug Critical Oct 19, 2016

Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-…

Nearby Manufacturers

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds