PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported May 4, 2022

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA

cGMP Deviations

Recall #
D-0794-2022
Affected scope
353964 units
Initiated
April 15, 2022
Verify with FDA Drug →
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Teva Pharmaceuticals USA Inc recalled Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-7… - a moderate-severity action.

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-7… was recalled by Teva Pharmaceuticals USA Inc in May 4, 2022. Reason: cGMP Deviations. Check the official notice for the remedy. Verify recall #D-0794-2022 with the FDA Drug before acting.

The recall

Teva Pharmaceuticals USA Inc issued this moderate-severity FDA Drug recall-cGMP Deviations.

Moderate
severity level
354K units
affected scope
Class II
classification
May 4, 2022
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0794-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) 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, 3 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.

Cosmetics & Personal Care recalls over time

Where this recall sits in its category - 1,371 cosmetics & personal care recalls on record

0100200300400 20052008201120142017202020232026 33
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA

Reason for recall

cGMP Deviations

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-0794-2022
Date reported May 4, 2022
Date initiated April 15, 2022
Recalling firm Teva Pharmaceuticals USA Inc
Firm location Parsippany, NJ
Affected scope 353964 units
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.

Scale of Impact

353964 units units affected - multi-state distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) ✓ This recall
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0794-2022) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

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.

Frequently Asked Questions

What product was recalled?
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA. Recalled by Teva Pharmaceuticals USA Inc. Units affected: 353964 units.
Why was this product recalled?
cGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on May 4, 2022. Severity: Moderate. Recall number: D-0794-2022.
Where was the recalled product distributed?
Distribution: Nationwide within the United States.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 7… → · All Cosmetics & Personal Care recalls

This recall: FDA Drug, reported May 4, 2022. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026