Severity
Low
FDA Drug recall · Reported November 6, 2019
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
AuroMedics Pharma LLC recalled Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mi… - a low-severity action.
Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mi… was recalled by AuroMedics Pharma LLC in November 6, 2019. Reason: CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.. Check the official notice for the remedy. Verify recall #D-0166-2020 with the FDA Drug before acting.
The recall
AuroMedics Pharma LLC issued this low-severity FDA Drug recall-CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty..
Sourced from official FDA Drug enforcement records. Verify recall #D-0166-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0166-2020) was formally reported on November 6, 2019, with the manufacturer initiating the action on September 23, 2019. It is classified under Low severity (Class III), with a current status of Ongoing. AuroMedics Pharma LLC is listed as the recalling firm, operating out of East Windsor, NJ. Federal records list the affected scope as 69696 bottles.
The documented reason for this recall is: CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty. Distribution data in the federal record shows the product reached: Nationwide within the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
69696 bottles
Related Recalls
6
5 from same agency
Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79
CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | D-0166-2020 |
| Date reported | November 6, 2019 |
| Date initiated | September 23, 2019 |
| Recalling firm | AuroMedics Pharma LLC |
| Firm location | East Windsor, NJ |
| Affected scope | 69696 bottles |
| Distribution | Nationwide within the United States |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported November 6, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.