CLASS II Drug recall · Reported 20 Dec 2023 · FDA Enforcement Report
Penicillamine Tablets USP 250 mg recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Penicillamine Tablets USP 250 mg. The recall was initiated on 22 Nov 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0148-2024
- FDA event ID
- 93482
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Penicillamine
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Nov 2023
- FDA classified
- 13 Dec 2023
- Reported
- 20 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 22 Nov 2023 | Recall initiated by company | |
| 13 Dec 2023 | Classified by FDA | +21 days |
| 20 Dec 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01
Where it was distributed
Product was distributed to 3 wholesale/distributor accounts.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot # M200498, Exp. June 2024
Where was it sold?
Product was distributed to 3 wholesale/distributor accounts.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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